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Generic Version of Wellbutrin SR Approved in 100mg Dose
Conversion of the 150 mg strength tentative approval to final approval is contingent upon any generic marketing exclusivity. Final approval also is dependent upon FDA's evaluation of any new information subsequent to the tentative approval.
"We are pleased to have received these important approvals and continue to work diligently with our partners, Teva (NASDAQ:TEVA) and Andrx (NASDAQ:ADRX), toward the final approval of the 150 mg strength," said Larry Hsu, Ph.D. IMPAX Laboratories, Inc. President.
IMPAX currently has 20 applications pending at the FDA, including five tentatively approved, which address over $7 billion in U.S. market sales for the 12 months ended November 30, 2003. Fifteen of these filings were made under Paragraph IV of the Hatch-Waxman Amendments.
Source: IMPAX Laboratories, Inc.